This invention relates in general to certain new and useful improvements in methods for reducing dysfunction in angioplasty procedures, and more particularly, to a kit which provides all components for the introduction of a selected amount of a prostaglandin compound into the artery in which an angioplasty procedure is performed and compositions containing specified amounts of the prostaglandin compound to produce a high degree of efficacy.
Angioplasty procedures were first used in the 1960's and since that time have gained widespread acceptance as a means of obtaining dilation of arteries. Particularly, angiomyocardial angioplasty procedures have become widely adopted to obtain dilation of myocardial arteries.
In the conventional angioplasty procedure, a small balloon tipped catheter is introduced into an artery, often using a guide wire to a catheter tube in which a balloon may be positioned at an artery stenosis. These balloons and catheter assemblies are often referred to as coronary balloon dilation catheters. In many cases, the catheters are designed to permit continued distal dye injections through the balloon to permit visual verification of proper approach to a lesion or other area in which the procedure is to be employed.
It is well known that cardiac angioplasty procedures involve a risk of both local and systemic thromboembolic effects, which are even greater than cardiac catheterization. Usually, the patient is injected with heparin and various known blockers during the procedure. Moreover, for a substantial period of time after the procedure, which may be six months to a year, or longer, the patient must necessarily be treated with platelet inhibiting drugs. Other complications which often occur during transluminal angioplasty procedures include dissection of an artery such as a coronary artery, intramural hematoma and occlusion of the artery resulting in myocardial infarction.
Some of the problems which appear to arise after angioplasty procedures include early restenosis and possibly abrupt occlusion. It is therefore necessary to provide some means which exhibits a cytoprotective effect during ischemia and which may salvage the myocardium during transluminal angioplasty, particularly when high inflation pressures are needed for a long duration, as for example, up to six minutes, or otherwise, in the case of an unstable angina.
In order to overcome some of the dysfunction resulting from percutaneous transluminal coronary angioplasty, heparin and intracoronary nitroglycerine, as well as systemic calcium blockers have been used. In addition, various preparations have been employed prior to the angioplasty procedures and include, for example, aspirin, Persantine, intravenous dextran, etc. Nevertheless, the various complications still persist. Moreover, these complications account for virtually all of the problems in percutaneous transluminal coronary angioplasty. In the NHLBI registery, as reported by Cowley, et al., in the American Journal of Cardiology, 1984, the results of the cases of 3,079 patients were examined and 418 patients suffered some form of post angioplasty procedure complications.